According to a recent study by the American Cancer Society, 46,000 women in the United States will die in 1993 from breast cancer. (From the 1993 World Almanac, published by Pharos Books.) Recent advances in diagnostic techniques and surgical treatments have helped to reduce the mortality rate due to breast cancer, but this disease is still the third greatest cause of death among women in this country. A variety of mammographic systems which employ X-rays and ultrasound have been developed over the past few decades, but this equipment is generally very large, prohibitively expensive and requires a trained technician to operate them. As an example, the minimum price of an ultrasonic imaging system sold by Acuson of Mountain View, Calif. exceeds $200,000. Several documents noted below disclose various systems that pertain to equipment that may be used for different kinds of medical diagnosis.
In U.S. Pat. No. 4,282,880, Gardineer et al. disclose a water conditioning system for maintaining and conditioning the water used in an ultrasound imaging system especially adapted to perform diagnosis of the human breast.
In his U.S. Pat. No. 4,737,109, Abramson discloses a method and apparatus for use in training persons in breast cancer detection by manual examination. The apparatus includes a device which is comprised of a body of elastomerically yielding material and one or more lumps embedded in the body, wherein the lump or lumps resemble a pre-determined type of lesion.
In their U.S. Pat. No. 4,793,354, Wright and Perry disclose a method of enhancing the sense of touch.
In his U.S. Pat. No. 4,867.686, Goldstein uses a model of a human female breast for teaching breast examination. Goldstein discloses a method of training a person to detect breast tumors by palpating a model of a human female breast having at least one simulated tumor.
In his U.S. Pat. No. 5,207,582, Michelson discusses a device for facilitating breast self-examination in order to speed up detection of breast cancer. The device has an information panel, instructions for conducting self-examinations and diagrams for recording the results. Recording means are also included with this device.
In their U.S. Pat. No. 5,479,661, Fingleson and Richman teach the use of a garment worn by a woman for self-examination of the breasts, the device having written and graphic instructions printed on it.
In his U.S. Pat. No. 4,130,112, Frazer describes an apparatus for ultrasonic scanning of a breast or other tissue. This invention includes a cavity for receiving the patient's breast, and a vacuum for drawing the breast into intimate contact with the walls of the cavity. The walls enclose ultrasonic transducers that are employed to create an image of the breast tissue.
U.S. Pat. No. 4,135,497 issued to Meyers et al. reveals an apparatus for detecting temperature variations over selected regions of living tissue. The inventors state that the method disclosed in their patent is useful for detecting malignant tissue in the breasts.
U.S. Pat. No. 4,206,763 issued to Pedersen discloses a device and a method for ultrasonic examination for carcinoma of the breast. Pedersen employs a compartment in which water is drawn upward by suction over the breast. An ultrasonic transducer then revolves around the breast to obtain complete 360 degree scans. A pleated flexible bag 12 pulls the breast into a water bath compartment 4 when the water bath compartment 4 is evacuated by a pair of bellows 16. (See Column 1, Lines 60-68; Column 3, Lines 23-51 and Column 4, Lines 4 & 5.)
U.S. Pat. No. 4,252,125 issued to Iinuma describes an ultrasonic diagnosing apparatus that utilizes a receptacle 11 filled with warm water 12. An ultrasonic probe 14 makes an image of the breasts, which are pressed against a flexible membrane 18 that is stretched in front of the probe. (See Column 1, Lines 65-68 and Column 2, Lines 1-7.)
U.S. Pat. No. 4,341,222 issued to Gardineer et al. relates to a patient support system for orienting a woman's breast over an ultrasound scanner. The patient is shown bent over a pool of water 20 that is positioned over a scanning transducer 14. (See Column 5, Lines 62-68 and Column 6, Lines 1-4.) The water serves as a transmission medium for the ultrasonic waves. (See Column 2, Lines 15 & 16.)
U.S. Pat. No. 4,347,850 issued to Kelly-Fry et al. discloses a direct water coupling device for ultrasound scanning. A tank 10 is placed in a sealed position about the perimeter of the breast area while the patient is in a supine position. (See FIG. 3 & Column 4, Lines 37-38.)
U.S. Pat. No. 4,545,385 issued to Pirschel describes an apparatus for ultrasonic examination of body parts using a fluid container and an ultrasound scanning system. (See FIG. 1.) A liquid-filled basin 6 serves as an acoustic coupling. (See Column 3, Lines 4-5 & Column 3, Lines 24-25.) U.S. Pat. No. 4,657,021 issued to Perry et al. concerns an apparatus which he claims enhances the sense of touch when placed between the fingertips of the user and the object being touched. A liquid lubricant 13 is captured inside a sealed enclosure 10 made from a pliable, elastic material. (See Column 2, Lines 36-40 and Column 3, Lines 4-18.)
U.S. Pat. No. 4,873,982 issued to Morrison contains a discussion of an examination garment that may be used to feel for lumps under the skin. (See FIGS. 1 and 3.)
U.S. Pat. No. 4,917,096 issued to Englehart et al. reveals the details of a portable ultrasonic probe. A fluid-filled enclosure is coupled to a handled portion which houses a drive motor. (See FIG. 3.) The probe 20 includes a fluid-filled enclosure 34. (See Column 4, Lines 30-31.)
U.K. Patent Application No. 2,111,347A by Robert Cribbs pertains to a method of pulse examination using a container that holds a liquid couplant. The container is placed about the breasts of a female torso, and breast tissue is scanned using ultrasound.
A brochure published by Metrix Incorporated of Deerfield, Ill. presents specifications for echo-scan and echo-trace ultrasonic analyzers. The brochure describes how high frequency, short duration electromechanical pulses emitted by special transducers in direct or indirect contact with a portion of the human body can produce visual information.
In her book entitled Dr. Susan Love's Breast Book, Susan M. Love describes conventional techniques for breast self-examinations. (See pp. 21-31).
The vast majority of literature published in both the academic and popular press suggests that the best weapon in the fight against breast cancer is early detection. The problem of providing a low-cost yet effective method for self-examination of portions of the human body has presented a major challenge to doctors and other health-care professionals. The development of methods and apparatus that enhance the prospects of detecting abnormalities during self-examinations would constitute a major technological advance and would satisfy a long felt need within the health-care field.